Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Soil Transmitted Helminthiasis (STH)

Phase 3

Not yet recruiting

• Conditions: Soil-Transmitted Helminthiasis (STH)
• Interventions: Drug: Placebo; Drug: ZP5-9676 600 mg dose

• Registration Number: NCT06128447
• Lead Sponsor: Zero Point Five Therapeutics

Brief Summary

This is a Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectiveness, safety, and tolerability of ZP5-9676 compared to placebo for the treatment of STH infections. Approximately 300 participants will be enrolled, randomized at the Baseline visit (Day 1) to one of the following treatments in a 1:1 ratio of active and placebo.

Detailed Description

Approximately 300 infected participants will be enrolled to ensure that there is a minimum of 114 hookworm-infected participants evaluable for the Test of Cure study visit (Day 14). Some participants may be co-infected and will be included in each tally.

Participants will be randomized (1:1) to one of the treatments below followed by standard of care treatment:

* Treatment A: ZP5-9676 600 mg dose

* Treatment B: Placebo

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Study Start: 2024-10-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Provide a signed informed consent form from the participant or parent/guardian, and assent by participant(as applicable per local requirements) and understand and agree to comply with required procedures in the study.
2. Male or female, who are 6 months to 59 years old, inclusive, and live in a high STH prevalence area
3. Positive for hookworm (A. duodenale or N. americanus), A. lumbricoides, and/or T. trichiura on microscopic examination of fecal samples.
4. Females of childbearing potential must use an acceptable method of contraception as determined by the Investigator from the initial Screening visit through 35 days after study drug administration. A female is considered to be of childbearing potential from menarche until after menopause (age >45 years with no menses for 12 months without an alternative medical cause) unless permanently sterile. Acceptable methods include abstinence, hormonal contraceptives, intrauterine device/system, vasectomy in the sole male sexual partner, tubal ligation, or double-barrier contraceptive method (male condom with female cervical cap, diaphragm, or sponge) with spermicide.
5. Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion.

Exclusion Criteria

1. Severe anemia (hemoglobin< 8 g/dL1).
2. Active diarrhea (passage of ≥3 loose or liquid stools per day).
3. Children (6 months to 17 years old) with significant wasting (moderate and severe-below minus two standard deviations from median weight for height of reference population).
4. Women who are pregnant.
5. Hypersensitivity or allergy to ZP5-9676 or any inert ingredients in the chewable formulation or other medications in the benzimidazole class.
6. Taken ZP5-9676 or any other treatment for STH infection within 30 days of screening or randomization.
7. Used an investigational medical device within 30 days of screening.
8. Preplanned surgery procedures within 30 days of screening.
9. History of a medical disorder causing difficulty in chewing or swallowing.
10. Participation in any investigational drug (including vaccine) trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the start of the study (time of first dose).
11. Participation in an interventional clinical study within 30 days of screening.
12. Any condition that interferes with the ability to understand or comply with the requirements of the study.
13. Any other medical condition, serious illness, or other circumstance that would place the subject at increased risk, as determined by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	Placebo	Placebo
Treatment A	ZP5-9676 600 mg dose	ZP5-9676 600 mg dose

Primary Outcome Measures

Name	Time	Method
Cure rates	14 days	Cure rates (CRs) for each STH

Secondary Outcome Measures

Name	Time	Method
Egg reduction	14 days	Egg reduction rates (ERRs) for hookworm
Cure rates	14 days	Cure rates of hookworm

Trial Locations

Locations (2)

Clínica de Vacinas; 🇧🇷 Americaninhas, Brazil

Noguchi Memorial Institute for Medical Research; 🇬🇭 Accra, Ghana